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This study is the most current\u2014and single most comprehensive\u2014research effort to investigate the safety and efficacy of maternal and prenatal exposure to methadone and buprenorphine.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The <jats:styled-content style=\"fixed-case\">MOTHER<\/jats:styled-content> study design is outlined, and its basic features are presented.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>At least seven important lessons have been learned from the <jats:styled-content style=\"fixed-case\">MOTHER<\/jats:styled-content> study: (i) an interdisciplinary focus improves the design and methods of a randomized clinical trial; (ii) multiple sites in a clinical trial present continuing challenges to the investigative team due to variations in recruitment, patient populations and hospital practices that, in turn, differentially impact recruitment rates, treatment compliance and attrition; (iii) study design and protocols must be flexible in order to meet the unforeseen demands of both research and clinical management; (iv) staff turnover needs to be addressed with a proactive focus on both hiring and training; (v) the implementation of a protocol for the treatment of a particular disorder may identify important ancillary clinical issues worthy of investigation; (vi) timely tracking of data in a multi\u2010site trial is both demanding and unforgiving; and (vii) complex multi\u2010site trials pose unanticipated challenges that complicate the choice of statistical methods, thereby placing added demands on investigators to effectively communicate their results.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1360-0443.2012.04036.x","type":"journal-article","created":{"date-parts":[[2012,10,29]],"date-time":"2012-10-29T16:30:49Z","timestamp":1351528249000},"page":"28-35","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":73,"title":["<scp>M<\/scp>aternal <scp>O<\/scp>pioid <scp>T<\/scp>reatment: <scp>H<\/scp>uman <scp>E<\/scp>xperimental <scp>R<\/scp>esearch (<scp>MOTHER<\/scp>)\u2014approach, issues and lessons learned"],"prefix":"10.1111","volume":"107","author":[{"given":"Hendr\u00e9e E.","family":"Jones","sequence":"first","affiliation":[{"name":"Departments of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology Johns Hopkins University School of Medicine  Baltimore MD USA"},{"name":"RTI International  Research Triangle Park NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Fischer","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychotherapy Medical University Vienna  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah H.","family":"Heil","sequence":"additional","affiliation":[{"name":"Departments of Psychiatry and Psychology University of Vermont  Burlington VT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karol","family":"Kaltenbach","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics and Psychiatry and Human Behavior Jefferson Medical College Thomas Jefferson University  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter R.","family":"Martin","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Vanderbilt University  Nashville TN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mara G.","family":"Coyle","sequence":"additional","affiliation":[{"name":"Department of Pediatrics The Warren Alpert Medical School of Brown University  Providence RI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Selby","sequence":"additional","affiliation":[{"name":"Department of Family and Community Medicine Department of Psychiatry Dalla Lana School of Public Health University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan M.","family":"Stine","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Neurosciences Wayne State University  Detroit MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin E.","family":"O'Grady","sequence":"additional","affiliation":[{"name":"Department of Psychology University of Maryland College Park  College Park MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amelia M.","family":"Arria","sequence":"additional","affiliation":[{"name":"Center on Young Adult Health and Development School of Public Health University of Maryland College Park  College Park MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2012,10,29]]},"reference":[{"key":"e_1_2_16_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1005359"},{"key":"e_1_2_16_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2012.04035.x"},{"key":"e_1_2_16_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2004.08.027"},{"key":"e_1_2_16_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2004.11.013"},{"key":"e_1_2_16_6_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.103.2.516"},{"key":"e_1_2_16_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/15.11.2433"},{"key":"e_1_2_16_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0029-7844(00)01075-9"},{"key":"e_1_2_16_9_1","volume-title":"Structured Clinical Interview for DSM\u2010IV Axis I Disorders","author":"First M. 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